510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Rio Drug Reconstitution Transfer Device
Icu Medical, Inc.
Powder free nitrile examination glove- black, non sterile
Hong Seng Gloves Sdn Bhd
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
Shanghai Handy Medical Equipment Co., Ltd.
Velocity Alpha MR High Speed Surgical Drill System
Adeor Medical AG
NSite Scoliosis Assessment App
Nsite, Inc.
LED Curing Lights (DB686 HALO)
Foshan Coxo Medical Instrument Co., Ltd.
ProLift Micro Expandable Spacer System
Life Spine, Inc.
CDI OneView Monitoring System
Terumo Cardiovascular Systems Corporation
Guided DAS Surgical Kit
Talladium España, SL
EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
K1 Medical, LLC
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.
Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbH
REAL INTELLIGENCE CORI
Blue Belt Technologies, Inc.
Philips IntelliSite Pathology Solution 5.1
Philips Medical Systems Nederland B.V.
FAICO Dental Implant System and CAD/CAM Abutments
Faico Medical, LLC
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
Ever Global (Vietnam) Enterprise Corporation
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
Surgical Instrument Services and Savings, Inc.
L12 LED Light Source with AIM
Stryker Endoscopy
BD Surgiphor Antimicrobial Irrigation System
Becton, Dickinson and Company
Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465
Covidien, LLC
NP Medical nCompass Extension Set with Stabilizing Base
Np Medical
ClearCheck (RADCC V2.7)
Radformation, Inc.
Nitrile Disposable Examination Gloves
Vista Industries,, LLC
WavelinQ Generator
C.R. Bard, Inc.
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
Shenzhen Hingmed Medical Instrument Co., Ltd.
3 Series NeoLux
Daavlin Distributing Co.
Vascette HP (hemostatic pad)
Koag, LLC
Osteotomy Wedge System
Sinaptic Surgical
RevealAI-Lung
Precision Medical Ventures, Inc. Dba Revealdx
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